BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SHELL

    MDR report key: 7266235 · Received February 13, 2018

    Report

    Report Number
    0001825034-2018-00821
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    October 13, 2016
    Report Date
    February 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT: (B)(4). MEDICAL PRODUCT: BIOLOX DELTA CERAMIC LINER CATALOG# 110003634 LOT# 3449644. DELTA CERAMIC FEMORAL HEAD CATALOG# 650-0660 LOT# 2015060755. TAPERLOC COMPLETE MICRO PRIMARY FEMORAL CATALOG# 51-1060900 LOT# 2802830. REPORT SOURCE: FOREIGN: THE EVENT OCCURRED IN (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOR SAME OR SIMILAR ISSUE IDENTIFIED ELEVEN COMPLAINTS FOR PART (ITEM) NUMBER AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED FOR PART/LOT COMBINATION. WITHOUT THE OPPORTUNITY TO EVALUATE THE DEVICE, THE COMPLAINT WAS NOT CONFIRMED AND ROOT CAUSE COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. ASSOCIATED RISK TABLE LISTS "MISCELLANEOUS USER NEEDS (GENERAL POST-OPERATIVE PAIN )¿. FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00822. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6) REPORTED THAT A PATIENT UNDERWENT A RIGHT HIP SURGERY ON (B)(6) 2016. SUBSEQUENTLY, THE PATIENT REPORTED RARE MODERATE PAIN RARELY AFTER UNUSUAL ACTIVITY, MAY TAKE ASPIRIN, IMPOSSIBLE TO GETTING IN OR OUT OF CAR, MODERATE DIFFICULTY SHOPPING AND CLIMBING STAIRS, LIMPING ALL THE TIME, PAIN IN BED AT NIGHT MOST NIGHTS DURING 6 MONTHS FOLLOW UP VISIT ON (B)(6) 2016. ADDITIONALLY, PATIENT REPORTED MODERATE TROUBLE GETTING IN OR OUT OF CAR, MODERATE DIFFICULTY SHOPPING AND CLIMBING STAIRS, LIMPING ALL THE TIME, PAIN IN BED AT NIGHT MOST NIGHTS DURING 1 YEAR FOLLOW UP VISIT ON (B)(6) 2017. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109417 G7 ACETABULAR SHELL PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3483207

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other